Regulatory Associate

Success through teamwork

We work together to find a better way and break new ground to make progress possible. Focused on common goals, we raise the standard and make a difference. We strive for excellence in everything we do.

At ICON, career possibilities can become realities for those who look for challenges and embrace learning and growth opportunities.

ICON Clinical Research is dedicated to providing the pharmaceutical and biotechnology industries with exceptional clinical research and biometrics services.

To continue our legacy of excellence, ICON Development Solutions, a dynamic and innovative Product Development Organization committed to helping pharmaceutical and biotech companies bring products through development from early stage to regulatory approval, is now the Strategic Pharmaceutical Development Division of ICON.

Join us in one of our current openings and enjoy highly competitive benefits and exceptional advantages.


Regulatory Associate
Ellicott City, MD or Redwood City, CA
ICON Development Solutions

The selected candidate will be responsible for compiling and processing US IND, CTD, Annual reports, DMF, NDA and BLA submissions and assisting with all Regulatory Affairs /Quality Assurance department needs. In this role, you will ensure timeliness of deliverables; edit/format/review regulatory documents; and work with staff in resolving regulatory issues and/or problems. Ensure that the company adheres to all applicable regulations. Additionally, you may serve as the team member for specific projects; be responsible for gathering and entering regulatory information related to specific projects; perform regulatory and/or quality assurance reviews of data or reports; attend project meetings, professional meetings, seminars and workshops; and document all phases of involvement in any specific project.

The qualified candidate will have a bachelor’s degree a relevant discipline, along with
1-2 years of experience in regulatory affairs or quality (or equivalent) is preferred. Knowledge of US FDA regulations is preferred. Must have excellent organizational and communication skills along with proficiency in MS Word and Excel. Must have excellent attention to details in reviewing written communications, including good understanding of English grammar and punctuation.


Come to ICON and be an important part of a well respected and growing company that believes the details of your career are every bit as critical as the work you do. You'll enjoy highly competitive benefits in addition to flexible scheduling, relocation assistance, tuition reimbursement, credit union, health club privileges, and many other exceptional advantages.

TO APPLY and for more information on our opportunities and locations, please visit us at http://www.iconclinical.com/index.asp?getpage=true&sid=10 . Job posting #293189. No agencies, please.

ICON. A Symbol of Excellence.

ICON Clinical Research is an Equal Opportunity Employer committed to strength in diversity.

www.iconclinical.com


To Apply for this position, please CLICK HERE